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Questions raised on inaccurate Vitamin D testing
The increasing list of conditions that low vitamin D is associated with has created a huge growth in vitamin D testing. But a presentation to a recent conference in the United States suggested that two of the newer tests for vitamin D are potentially inaccurate. A recent item from the ABC Health report talks about about these potential inaccuracies and we get an Australian perspective. ABC Health Report (note -16 minute Audio)
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Simple saliva test detects head and neck cancers early
The loss of a family member to cancer has inspired a Queensland medical researcher to look for a no-fuss test to detect the disease early by screening saliva.Dr Chamindie Punyadeera is working on a saliva test for early detection of head and neck cancers, hoping to replicate her success in developing a non-invasive saliva test that detects heart disease in 70% of patients National Nine News
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Bloodless glucometer for diabetes
Grove Instruments has completed a pilot study of its bloodless glucometer designed to allow diabetes patients to opt out of finger-prick tests. The Optical Bridge technology, which makes use of near-infrared spectroscopy, takes less than 20 seconds to check a patient's blood glucose levels in real time. MedCityNews.com |
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U.S. Army funds development of rapid blood-screening test
The U.S. Army has awarded Canadian company MedMira a contract worth more than $4 million for the development of its Multiplo Rapid HBV/HIV/HCV Antibody Test. The test will be used for quick testing of blood for HIV and hepatitis B and C before emergency transfusions. The U.S. Army will also shoulder development costs and related fees for getting FDA pre-market approval for the test. United Press International |
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FDA Proposes Unique Identification System for Medical Devices
The FDA has proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety, according to the agency. |
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FDA approves Qiagen's therascreen KRAS test for colorectal cancer
Qiagen announced recently it received FDA approval to market the therascreen KRAS RGQ PCR Kit to identify patients with colorectal cancer most likely to benefit from Bristol-Myers Squibb and Eli Lilly's Erbitux (cetuximab). According to FDA spokesman Michelle Bolek, this is the first FDA-approved diagnostic that will evaluate each patient’s likelihood of responding to the cancer treatment. FirstWord MedTech |
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Legal Fight over Gene Patents continues
The AMP vs. Myriad case is to be the subject of oral hearings at the US Supreme Court, just months after its ruling in the Prometheus Case. Both the pathology profession and biotech industry have much at stake in how Supreme Court rules in this important case involving the patentability of genes Dark Daily |
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Canada widens medtech, drug regulatory transparency effort
Health Canada plans to broaden its Summary Basis of Decisions effort, which aims to release public reports on regulatory decisions regarding certain medical devices and drugs. The transparency effort is being expanded to include data on decisions in the post-marketing stage and to cover biosimilars as well as Class IV and III medical devices with novel technologies. |
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Thermo Fisher Buying Transplant Dx Firm for $925M
Thermo Fisher Scientific announced it intends to buy transplant diagnostics firm One Lambda for $925 million in cash. Founded in 1984, the Canoga Park, Calif.-based One Lambda develops tests that are used by transplant centers for tissue typing, mainly for determining compatibility between donors and recipients and for detecting the presence of antibodies that can result in transplant rejection. Medical News.net |
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Researchers Predict that Aging Populations in Europe Will Increase Clinical Pathology Testing
Researchers predict that aging populations in Europe will increase clinical pathology laboratory testing volumes by 69.5% in only 7 years. Are clinical laboratories in Australia and elsewhere capable of meeting the expected surge of medical laboratory testing that is expected to come as large numbers of people age into their 60s and 70s? Dark Daily |
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U.K. agency issues guidance on regulation of IVDs for self-testing
New guidance from the U.K. Medicines and Healthcare products Regulatory Agency outlines how notified bodies should review the labeling and design of in vitro diagnostics designed for self-testing. The guidance mirrors the growing focus on the role of design and instructions for use by lay users as the European Commission mulls changes to the current IVD Directive. |
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EKF Introduces POC HbA1c Diabetes Test
A test for rapid detection and management of diabetes has been introduced by EKF Diagnostics of Cardiff, Wales. Called Quo-Test, the POC analyzer measures glycated hemoglobin (HbA1c) using a patented boronate fluorescence quenching technology that is not affected by hemoglobin variants. IVD Technology |
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Bayer in discussions to sell diabetes device unit
According to a report in the Financial Times Deutschland, Bayer is in talks to sell its blood glucose meters business. The newspaper, citing sources close to the matter, indicated that companies interested in the unit included Sanofi and Panasonic, although a spokeswoman for the latter denied it was looking to buy the business. FirstWord MedTech |
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